Thrombogenic Factors and Recurrent Coronary Events
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Coronary Disease
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005358
First Posted
May 25, 2000
Last Updated
January 14, 2016
Sponsor
University of Rochester
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005358
Brief Title
Thrombogenic Factors and Recurrent Coronary Events
Study Type
Observational
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 1994 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 1999 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Rochester
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To determine if selected circulating blood factors that reflect enhanced thrombogenesis are associated with an increased incidence of recurrent coronary events, including cardiac death or non-fatal myocardial infarction.
Detailed Description
DESIGN NARRATIVE:
In this multicenter, collaborative, prospective study, patients hospitalized with a myocardial infarction were enrolled from ten geographically dispersed centers. Five thrombogenic- related blood factors were quantitated, and formed the centerpiece of this study: 1) lipoprotein(a) [Lp(a)] - a quantitative genetic factor that contains apolipoprotein B, has a structural homology to plasminogen, interferes with intrinsic thrombolytic activity, and represents a crossover link in the thrombogenesis/atherogenesis hypothesis; 2) soluble fibrin - a system indicator of coagulation activity in the ongoing conversion of fibrinogen to insoluble fibrin strands; 3) plasminogen activator inhibitor-1 (PAI-1) - an important regulator of the fibrinolytic system, it interferes with intrinsic t-PA activity; 4) coagulation Factor VII -high levels lead to increased thrombogenesis and have been associated with an increased risk of ischemic heart disease; and- 5) von Willebrand factor - it binds to platelet glycoproteins, contributes to local thrombus formation, and it is elevated in patients at increased risk of coronary thrombosis.
The primary analysis utilized a time-dependent survivors hip model (Cox regression) to determine the presence or absence of an association between one or more of these factors and subsequent thrombotic-related coronary events. Secondary objectives included: 1) to determine if there was a statistical association between the thrombogenic factors and conventional hematologic/lipid parameters, and to evaluate their interactions regarding coronary events; and 2) to determine if thrombogenic factors had uniform effects on coronary event rates across various subgroups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Coronary Disease, Myocardial Infarction, Thrombosis, Death, Sudden, Cardiac
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur Moss
Organizational Affiliation
University of Rochester
12. IPD Sharing Statement
Citations:
PubMed Identifier
10595629
Citation
Marder VJ, Zareba W, Horan JT, Moss AJ, Kanouse JJ. Automated latex agglutination and ELISA testing yield equivalent D-dimer results in patients with recent myocardial infarction. THROMBO Research Investigators. Thromb Haemost. 1999 Nov;82(5):1412-6.
Results Reference
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PubMed Identifier
10330382
Citation
Moss AJ, Goldstein RE, Marder VJ, Sparks CE, Oakes D, Greenberg H, Weiss HJ, Zareba W, Brown MW, Liang CS, Lichstein E, Little WC, Gillespie JA, Van Voorhees L, Krone RJ, Bodenheimer MM, Hochman J, Dwyer EM Jr, Arora R, Marcus FI, Watelet LF, Case RB. Thrombogenic factors and recurrent coronary events. Circulation. 1999 May 18;99(19):2517-22. doi: 10.1161/01.cir.99.19.2517.
Results Reference
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Thrombogenic Factors and Recurrent Coronary Events
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